BEUDAMED
    FDA Registration Active 🇺🇸 United States

    OtoSet - Ear Cleaning System

    Reg #: 3017567810 · FEI: 3017567810 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    SafKan, Inc.
    Registration Number
    3017567810
    FEI Number
    3017567810
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4008 148th Ave Ne
    City
    Redmond
    State
    WA
    ZIP
    98052
    Country
    US

    Regulatory Submissions

    510(k) Number
    K201877

    Owner / Operator

    Firm Name
    SafKan, Inc.
    Operator Number
    10078836
    Address
    4008 148th Ave NE
    City
    Redmond
    State
    WA
    Postal Code
    98052
    Country
    US
    Correspondent
    Sahil Diwan

    Products

    Device Name Product Code
    Applicator, Ent Drug LRD
    Syringe, Irrigating (Non Dental) KYZ

    Proprietary Names

    OtoSet - Ear Cleaning System OtoSet

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility